New Assay to Support Clinical Drug Development for Autoimmune Diseases

PROTAGEN AG, a provider of pharma development services, companion diagnostics and novel diagnostic tests in the fields of immuno-oncology and autoimmune disease, has announced the launch of NavigAID SSc, a disease stratification assay designed to support pharmaceutical and biotechnology companies with their Systemic Sclerosis (SSc) drug development efforts.

SSc is a severe autoimmune disease of the connective tissue with extreme heterogeneity in clinical presentation and unpredictable clinical course. It is characterized by tissue fibrosis and vascular injury in the skin and internal organs.

NavigAID SSc is the latest addition to the Protagen NavigAID product line. Building on the successful launch of NavigAID SLE in April 2015, NavigAID SSc is a novel stratification assay that enables the distinct segregation of patient subgroups via the measurement of serum biomarkers, thereby increasing the probability of success in both SSc treatment and clinical drug development.

“The World Scleroderma Foundation reports that approximately 2.5 million individuals worldwide suffer from SSc, which in its more aggressive form is the most fatal of all rheumatologic disorders. Unfortunately, the extreme clinical diversity of the disease means that no two patients are truly alike, a fact that has hindered much-needed medical progress,” said Bernd Kirschbaum, former Merck Pharma Executive and Chairman of the Protagen Board of Directors. “Addressing the SSc heterogeneity challenge is crucial for the clinical development of effective and curative therapies. The new NavigAID SSc does exactly this.”

Protagen NavigAID SSc has been specifically developed to tackle the heterogeneity challenge associated with SSc and it facilitates the development of new therapies by employing existing and new proprietary serum biomarkers. Taking a unique disease stratification approach, NavigAID SSc enables differential diagnosis, risk stratification and prediction of organ involvement. Additionally, NavigAID SSc has the potential to provide the basis for treatment-specific companion diagnostics (CDx).

“Our innovative NavigAID concept has been specifically designed to address the growing unmet need for novel diagnostic biomarkers and assays for precise disease characterization, patient stratification and therapy response prediction. As such, it is set to benefit any new SSc clinical development program,” added Georg Lautscham, Chief Business Officer at Protagen. “Continuing on this path, we are currently working on additional NavigAID product line extensions across other therapies and indications, such as checkpoint inhibitor therapies in immuno-oncology, cancer vaccines, rheumatoid arthritis and Sjögren’s Syndrome.”